Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation. (AMADEUS)

AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.

This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual".

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Atrial Fibrillation; Signs and Symptoms; Health Economy
• Intervention / Treatment: Other: Internet-based education

Detailed Description

In the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. The investigators developed an Internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.

The aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulla Walfridsson, RN PhD; Phone Number: +46 101033711; Email: ulla.walfridsson@regionostergotland.se
• Study Contact Backup: Name: Hakan Walfridsson, MD PhD; Phone Number: +46 101032199; Email: hakan.walfridsson@regionostergotland.se

Study Locations

• Sweden
  • Närke
    • Örebro, Närke, Sweden
      • Not yet recruiting
      • Dept of Cardiology, University Hospital
      • Contact: Dritan Poci, MD PhD; Phone Number: +46 19602 10 00; Email: dritan.poci@regionorebrolan.se
  • Ostergotland
    • Linkoping, Ostergotland, Sweden, 58185
      • Recruiting
      • Dept of Cardiology, HMC, University Hospital
      • Contact: Ulla Walfridsson, RN PhD; Phone Number: +46 101033711; Email: ulla.walfridsson@regionostergotland.se
      • Contact: Hakan Walfridsson, MD PhD; Phone Number: +46 101032199; Email: hakan.walfridsson@regionostergotland.se
  • Småland
    • Jönköping, Småland, Sweden
      • Not yet recruiting
      • Dept of Internal Medicine, County Hospital
      • Contact: Marija Jakovlevski Hedback, MD; Phone Number: +46 10241 00 00; Email: marija.jakovlevski.hedback@rjl.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care as usual; Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation.
Active Comparator: Internet-based education; Patients randomized in this arm receive an Internet-based educational program in addition to extended written information. This includes 6 steps with detailed information on background, symptoms, investigations, treatment options, life-style as well as one part with guides to self management.	Other: Internet-based education; A six-step Internet-based patient education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden	Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)	One year after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)	One year after randomisation
Health economy	Health-care costs during the year prior to the study and for the two arm during the study period	One year prior to and one year after randomisation

Collaborators and Investigators

• Sponsor: Ulla Walfridsson
• Collaborators: Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.; Dept of Cardiology, Örebro University Hospital, Sweden
• Investigators: Study Chair: Ulla Walfridsson, RN PhD, Dept of Cardiology, IMH, Linkoeping University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Health-related quality of life; Health economy; Symptom burden
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LiU Amadeus 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No